Kornimate/medical-research-clean huggingface dataset:
the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life. we hypothesized that improvements would be seen in all of the above outcomes.


Eligibility criteria:
inclusion criteria: * males and females with ra * over 18 years of age * acr functional class i and ii * taking remicade \>4 months exclusion criteria: * presence of comorbid conditions contraindicated to exercise, including, but not limited to: 1. heart disease 2. severe osteoporosis: (if \>50 years): t score \< -3.0 for hip or spine excluded; t score \<-2.5 for hip or spine w/o current treatment) 3. (all potential subjects) previous non-traumatic fractures 4. uncontrolled bp * bmi \>40 * regular use of assistive walking device which would interfere with ability to lift weights * currently or within the last 3 months participating in aerobic exercise \> 150 minutes a week * currently or within the last 3 months participating in any regular strength training activities * presence of neurological impairment that directly limits ability to perform exercise * participation in concurrent exercise study * any reason for which the investigator deems it would not be in the patient's best interest to continue in the study * plans to move away from site within next 1 year
a study of subjects with psoriatic arthritis to investigate the effectiveness of adalimumab introduction compared with methotrexate dose escalation (control)

Conditions: Psoriatic Arthritis

Summary: an interventional phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (psa) consisting of 2 parts: part 1 (day 1 up to week 16) is designed to compare the achievement of minimal disease activity (mda) between participants randomized to either adalimumab in combination with methotrexate (mtx) or mtx alone escalated to the highest recommended or tolerable dose; part 2 (week 16 through week 32) is designed to evaluate the maintenance or achievement of mda on 4 different treatment regimens using adalimumab and/or mtx, with participant allocation based on the initial randomized treatment and achievement of mda in part 1, and with rescue treatment option.


Eligibility criteria:
inclusion criteria: 1. psa diagnosis established at least 4 weeks prior to the date of the screening visit and confirmed by classification of psoriatic arthritis (caspar) criteria 2. not in mda at the time of screening 3. has 3 or more tender and 3 or more swollen joints 4. treated with methotrexate 15 mg (weekly) for at least 4 weeks exclusion criteria: 1. contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients 2. history of methotrexate intolerance/toxicity 3. medical conditions(s) precluding methotrexate dose increase above 15 mg 4. had prior exposure to any tumor necrosis factor (tnf) inhibitor, other mechanism of action biologic dmard (bdmard) or any systemic biologic agent in general

Keywords: psoriatic arthritis
a multicenter, open-label, pilot study of soticlestat (tak-935/ov935) in participants with 15q duplication syndrome (dup 15q) or cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (arcade study)

Conditions: 15q Duplication Syndrome; CDKL5 Deficiency Disease

Summary: the purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with dup15q or cdd during the maintenance period.

the drug being tested in this study is called soticlestat. soticlestat is being tested to treat people with dup 15q or cdd. this study will assess the effects of tak-935 on seizure frequency, safety. the study will enroll approximately 30 participants. participants will be enrolled into 2 groups based on their diagnosis as: dup 15q or cdd. all participants will be asked to take soticlestat tablets twice daily with or without food. the study comprises of 2 periods: screening/baseline period and treatment period (dose optimization and maintenance). the overall time to participate in this study is approximately 30 weeks, including 4 to 6 weeks screening/baseline period, 20 weeks treatment period, 2 weeks taper, and 2 weeks safety follow up period. participants completing this study will have an option to enroll in the open-label extension (ole) study, under a separate protocol.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of dup 15q or cdkl5 deficiency disorder. 2. currently taking 1 to 6 antiepileptic drugs (aeds) at a stable dose. exclusion criteria: 1. two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation. 2. currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.

Keywords: drug therapy 15q duplication syndrome (dup15q) cdkl5 deficiency disorder (cdd) brain diseases epilepsy central nervous system diseases autism cholesterol 24s-hydroxylase inhibitor anti-epilepsy drug anticonvulsants
the burden of access in duchenne muscular dystrophy in the us

Conditions: Duchenne Muscular Dystrophy

Summary: this study is being conducted to determine if dmd patients / families and healthcare providers experience burdens related to access, and if so, to identify them, and to determine life impacts to the patient, if any, of these burdens. data from healthcare providers will be collected by an online survey and from patients/families by one on one telephone interview.

patient/parent portion in this non-interventional study, dmd patients / parents of dmd patients will be interviewed to gather qualitative input, in the patient's voice, regarding challenges associated with access to medications, services and medical equipment, and how these burdens impact quality of life. healthcare provider portion in this non-interventional study, healthcare providers who see patients with dmd and who deal with insurance issues on behalf of dmd patients will participate in an online survey designed to determine the burden associated with access to medications, services and medical equipment.

Eligibility criteria:
inclusion criteria: patient/parent interviews * patients residing in the us who have been diagnosed with dmd who are age 18 years or older, or the parent / legal guardian of a person of any age who has been diagnosed with dmd, * have provide "proof of dmd" to ensure that they are impacted by the disease, * who have provided sufficient information in the rsvp process to determine their functional status; ambulatory, transitional or non-ambulatory, * state that they are the person who deals with insurance issues for the affected patient and, * who are able to understand and consent to participation in the study healthcare provider survey * healthcare providers (physicians, nurse practitioners, and physician assistants) currently involved in the care of patients with dmd * are currently practicing in the us, * who have provided sufficient information in the survey screening to determine that they currently care for dmd patients, * state that they and/or persons on their staff interface with insurance companies for dmd patients related to access to medications, services and/or medical equipment and, * who are able to understand and consent to participation in the study exclusion criteria: * there are no stated exclusion criteria in this study. study population must meet all inclusion criteria in order to be deemed eligible to participate.
safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of gsk573719 and gw642444 in subjects with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled gsk573719 and gw64244 compared to placebo, in subjects with copd.

this is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of gsk573719 (500mcg) inhalation powder and gw642444 (25mcg) inhalation powder administered once-daily via a novel dry powder inhaler (novel dpi) over 28 days in subjects with copd

Eligibility criteria:
inclusion criteria: * a signed and dated written informed consent prior to study participation * males or females of non-childbearing potential * 40 or more years of age * copd diagnosis * 10 pack-years history or greater of cigarette smoking * post-bronchodilator fev1/fvc ratio of 0.70 or less * post-bronchodilator fev1 of 80% or less of predicted normal exclusion criteria: * current diagnosis of asthma * other significant respiratory disorders besides copd, including alpha-1 deficiency * previous lung resection surgery * significant abnormalities in chest x-ray presentation * use of oral steroids, antibiotics or hospitalization for a copd exacerbation within 3 motnhs prior screening * any significant disease that would put subject at risk through study participation * bmi greater than 35 * pacemaker * significantly abnormal ecg, holter, or clinical lab finding (including hepatitis b or c) * cancer * allergy or hypersensitivity to anticholinergics or inhaler excipients * diseases that would contra-indicate the use of anticholinergics * use of oral corticosteroids within 6 weeks of screening * use of long-acting beta-agonists within 48 hours of screening * use of tiotropium within 14 days of screening * use of theophyllines or anti-leukotrienes within 48 hours of screening * use of short-acting bronchodilators within 4 hours of screening * use of investigational medicines within 30 days of screening * use of high dose inhaled corticosteroids * use of long-term oxygen therapy, cpap or nippv * previous use of gsk573719 or gw642444

Keywords: long-acting beta2-receptor agonist safety and tolerability pharmacodynamics pharmacokinetics long-acting muscarinic receptor antagonist copd
epicutaneous 1-chloro-2, 4-dinitrobenzene (dncb) patch in hiv infection.

Conditions: HIV Infections

Summary: to evaluate the efficacy of dinitrochlorobenzene (dncb) in patients with early hiv infection by monitoring immunologic parameters and serum hiv rna. to facilitate the understanding of possible alterations in the immunological status of the hiv+ patient cohort.


Eligibility criteria:
inclusion criteria patients must have: * either hiv negative or documented hiv+ by both the elisa and western blot tests. for hiv+ patients: * patients must fail to meet the aids-defining criteria. * cd4 lymphocyte count between 200 - 500 cells/mm3. exclusion criteria co-existing condition: excluded: patients with obvious ultra violet(uv)-irradiated skin damage in the treatment sites. concurrent medication: excluded: * patients who are likely to commence antiretrovirals within the 6-month study period. * patients using other immunomodulator therapies or other alternative therapies. * patients likely to require chemotherapy during the course of the study. concurrent treatment: excluded: * patients who are likely to require significant uv light exposure during the study period. * patients who are likely to require radiation therapy during the course of the study. prior medication: excluded: * prior exposure to dncb. * patients who have used antiretroviral medications within the previous 3 months.

Keywords: cohort studies rna, viral administration, cutaneous anti-hiv agents dinitrobenzenes
microvascular insulin resistance and mixed meal challenge

Conditions: Insulin Resistance

Summary: insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test. however, high blood glucose levels during this test may adversely impact on microvascular function. investigators will determine whether a liquid mixed meal challenge (from carbohydrate, protein and fat) is a more appropriate test for assessing microvascular-derived insulin resistance.

after consuming a meal, 80% of glucose is disposed in skeletal muscle. our research group has demonstrated that microvascular blood flow in skeletal muscle plays an integral role in this process. physiological doses of insulin stimulate microvascular blood flow, and that this increase is associated with enhanced glucose uptake by muscle. this microvascular action of insulin is lost during insulin resistance and type 2 diabetes. the oral glucose tolerance test (gtt) is the gold standard for assessing insulin resistance and pre-diabetes and is used world-wide. however high blood glucose levels following a glucose load may adversely impact on microvascular function. the aim of this project is to determine whether a mixed meal challenge (liquid drink consisting of carbohydrate, fat and protein) is a better test for assessing microvascular-derived insulin resistance.

Eligibility criteria:
inclusion criteria: * aged 18-70 years. * normal to overweight (bmi 19-35 kg/m2). * normotensive (seated brachial blood pressure \<160/100 mmhg). * considered healthy (hba1c \<6.5 %) or have clinically diagnosed type 2 diabetes. * either have a parent with t2d, or no family history of type 2 diabetes for two generations. * have given signed informed consent to participate in the study exclusion criteria: * age \ 70 yrs * morbidly obese with a bmi ≥36 kg/m2 * history of myocardial infarction or stroke * history of malignancy within past 5 years (except for non-melanoma skin cancers) * current smoker * history of severe liver disease * history of drug or alcohol abuse * elective major surgery during the course of the study * pregnancy/lactation * participation or intention to participate in another clinical research study during the study period.

Keywords: microvascular insulin resistance mixed meal glucose tolerance
the krill ageing muscle mechanisms (kamm) study

Conditions: Sarcopenia

Summary: this study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. the studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oil objective 1) muscle structure and function hypothesis: krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length). objective 2) neuromuscular control and central nervous system (cns) function hypothesis: krill oil supplementation will improve neuromuscular junction (nmj) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy. objective 3) gait and functional characteristics hypothesis: krill oil supplementation will improve gait and functional characteristics.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \</= 30 kg/m2 * age \>/= 65 years * capacity to consent * living within the glasgow area exclusion criteria: * diabetes mellitus * severe cardiovascular disease * seizure disorders * uncontrolled hypertension (\>150/90mmhg) * active cancer or cancer that has been in remission \<5 years * participation in any resistance exercise training within the last 6 months * impairments which may limit ability to perform assessments of muscle function * dementia * fish/shellfish allergy * taking medication known to affect muscle (e.g. steroids, selective serotonin reuptake inhibitors) or anticoagulants (e.g. warfarin) * taking omega-3 supplements in the last 3 months * regularly consuming 1 or more portions of oily fish per week * not able to understand english

Keywords: krill oil muscle strength neuromuscular function physical function
does the addition of divalproex sodium er to an atypical antipsychotic drug (apd) improve cognition and psychopathology in outpatients with schizophrenia (sch) or schizoaffective disorder (sad)?

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. it has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium er can improve cognitive impairment in patients. the major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.

Eligibility criteria:
inclusion criteria * male or female, age 18-65 * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * treated with olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone monotherapy for at least three months prior to enrollment * able to provide written consent exclusion criteria * primary dsm-iv diagnosis other than schizophrenia or schizoaffective disorder * treatment with any antipsychotic other than olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone in the past three months * treatment with a mood stabilizer or an antidepressant continuously in the past three months. patients who have had it for less than two weeks continuously will be permitted to enter. * pregnant or lactating females

Keywords: schizophrenia, cognition, mood stabilizer
aging brain structure and memory in response to exercise

Conditions: Mild Cognitive Impairment

Summary: this study will measure brain structure through its mechanical properties, assessed with magnetic resonance elastography, and determine whether it improves with aerobic exercise in older adults with low memory abilities. additionally, this study will determine if memory abilities improve with exercise and if they are related to brain structure. overall, this project has the potential to identify how brain health is impacted by exercise in older adults.

mechanical properties of the human brain, measured with magnetic resonance elastography (mre), reflect the health of brain tissue. our previous research has shown that these mechanical properties of the hippocampus are highly sensitive to memory function in young adults. based on these findings, we believe that these mechanical properties may be strong indicators of memory health in older adults and populations experiencing decline in memory function (i.e. mild cognitive impairment, mci). further, our results indicate these properties and associated functions are positively impacted by fitness and exercise training, thus making them potentially ideal markers for brain health in assessing rehabilitation. the objective of this research is to examine these properties in older adults with and without mci. we will do the following: (1) determine if there are differences in mechanical properties of memory systems in older adults with and without mci; (2) establish structure-function relationships between mechanical properties and memory performance in the older adult population; and (3) determine if both mechanical properties and memory performance are impacted by cardiovascular health, both through cross-sectional assessment of aerobic fitness and longitudinal response to exercise training.

Eligibility criteria:
inclusion criteria: * cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation * age 60-90 years * mmse score \>24 at time of initial consent exclusion criteria: * major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years) * neurological or autoimmune conditions affecting cognition (e.g. parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct) * other systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure, diabetes, chronic obstructive pulmonary disease, liver diseases, hypertension) * current medication use likely to affect cns functions (e.g. long active benzodiazepines) * failed outcome on the baseline graded exercise test * hypertension (systolic 130+ mmhg or diastolic 80+ mmhg) from baseline blood pressure measurement * claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of mri scanning * concussion within last 2 years and more than 3 lifetime concussions * current smoking (including marijuana) within the past 3 months

Keywords: exercise memory brain
eptinezumab in participants with episodic cluster headache

Conditions: Cluster Headache, Episodic

Summary: the purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic cluster headache (ech)

eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the placebo-controlled period and active treatment period of the study. the total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Eligibility criteria:
inclusion criteria: * the participant has episodic cluster headache, as defined by international headache society (ihs) international classification of headache disorders 3rd edition (ichd-3) classification, with an adequately documented record or reliable history of ech of at least 12 months prior to screening visit 1. * the participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated. * the participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine). * the participant is, at screening visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to screening visit 2. * the participant has a medical history of first symptoms of cluster headache from ≤60 years of age. exclusion criteria * the participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (cgrp) pathway (anti-cgrp monoclonal antibodies \[mabs\] and gepants). * the participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome). * the participant has a history or diagnosis of hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). * participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening visit 2 are also excluded. * the participant is, at screening visit 2, at significant risk of suicide. * the participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). other inclusion and exclusion criteria may apply.